Study of Safety and PK of AZD0543 in Healthy Adults
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of AZD0543 in Healthy Adults
1 other identifier
interventional
144
1 country
2
Brief Summary
The purpose of this study is to assess the safety and PK of AZD0543 compared to placebo in healthy adults 18 to 55 years of age. AZD0543 or placebo will be administered as single IM or IV dose. The study duration will be approximately 12 months for each participant following administration of IMP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2026
CompletedStudy Start
First participant enrolled
August 31, 2026
CompletedFirst Posted
Study publicly available on registry
September 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 20, 2027
September 17, 2026
September 1, 2026
7 months
August 28, 2026
September 15, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Immediate AEs within 1 hour of IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Within 1 hour of IMP administration
Injection/infusion-related reactions
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Within 24 hours of IMP administration
Injection/infusion site reactions
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Through Day 8 post-IMP administration
AEs
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Through Day 91 post-IMP administration
SAEs, MAAEs, and AESIs
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Throughout the study post-IMP administration
Secondary Outcomes (10)
AZD0543 serum concentrations over time
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Cmax
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Tmax
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 t½λz
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUClast
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
- +5 more secondary outcomes
Study Arms (6)
Cohort 1: Low Dose AZD0543
EXPERIMENTALParticipants will receive a single AZD0543 dose.
Cohort 1: Placebo
PLACEBO COMPARATORParticipants will receive a single dose of placebo.
Cohort 2: Medium Dose AZD0543
EXPERIMENTALParticipants will receive a single AZD0543 dose.
Cohort 2: Placebo
PLACEBO COMPARATORParticipants will receive a single dose of placebo.
Cohort 3: High Dose AZD0543
EXPERIMENTALParticipants will receive a single AZD0543 dose.
Cohort 3: Placebo
PLACEBO COMPARATORParticipants will receive a single dose of placebo.
Interventions
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1.
Eligibility Criteria
You may qualify if:
- Age 18 to 55 years
- Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range ≥ 18.0 kg/m2 to ≤ 30 kg/m2
You may not qualify if:
- Hypersensitivity to IMP/components
- Severe adverse reaction/hypersensitivity to other mAbs
- Acute fever/illness/infection within 3 days of planned dosing
- Clinically important illness/procedure/trauma within 4 weeks of IMP administration
- Active infection with Hepatitis B/C
- Clinically significant bleeding disorders
- Known/suspected immune deficiency/suppression
- Receipt of blood products/immunoglobulins or immunosuppressive therapies within 6 months prior to screening (immunosuppressive medications/therapies include glucocorticoids exceeding 2 weeks of prednisone (or equivalent) 20mg daily or every other day)
- Malignancy within previous 5 years; except treated non-melanoma skin cancers and locally treated cervical cancer
- Receipt of any licensed/investigational hMPV vaccine, other therapies and procedures as applicable; participation in other clinical studies
- Screening Abnormalities: clinically significant ECG, positive drug panel, Hgb/platelets/WBC outside of reference; all SCr/AST/ALT \> 1.5X ULN
- Women who are pregnant, lactating, or of childbearing potential and not using a highly effective birth control method
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Los Alamitos, California, 90720, United States
Research Site
South Miami, Florida, 33143, United States
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2026
First Posted
September 17, 2026
Study Start
August 31, 2026
Primary Completion (Estimated)
March 24, 2027
Study Completion (Estimated)
December 20, 2027
Last Updated
September 17, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.